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Completed

NCT Number: NCT00583180

Sensory Function After Wound Instillation of Capsaicin

The use of capsaicin as a potential analgesic drug for postoperative pain relies on the ability of capsaicin to induce membrane lysis of c-nerve fibers. In a previous randomized placebo controled blinded study of this effect we found a significant effect of capsaicin versus placebo. Before surgery all patients were examined by quantitative sensory testing to evaluate sensory function. In this study an identical sensory testing will examine if changes to the sensory function in capsaicin treated patients is identical to placebo treated patients.No new intervention will be performed

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Key information

Conditions

Primary Hyperalgesia Hyperalgesia Hypesthesia Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Hørshol Sygehus

Hørsholm, 2970, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary groin hernia planned to undergo Lichtenstein mesh repair
  • Ability to use pain scales
  • American Society of Anesthesiologist class I or II based upon medical history, physical examination, and screening laboratory results
  • Willing to take oral pain medication (acetaminophen, ibuprofen) for the first week
  • Willing to fill out a diary for four weeks following surgery.

Exclusion criteria

  • A previous lower abdominal surgical procedure
  • Bupivacaine, acetaminophen, ibuprofen, or tramadol
  • A medical condition likely to alter wound healing or pain ratings
  • Systolic blood pressure greater than 150 or diastolic greater than 95 mm Hg
  • Contraindication to general anesthesia
  • Bilateral hernia repair
  • A history of drug or alcohol abuse within the past two years
  • Use of antihypertensive, antidepressant, or psychotropic drug that has not been stable for 3 months
  • Use of an investigational drug within 3 months or scheduled to receive an investigational drug other than ALGRX 4975 during the study period.

Treatment and study plan

Capsaicin

Drug

instillation of sterile water or 1000 micrograms of capsaicin into the wound at the end of open groin hernia surgery in previous study.no new intervention will be performed in the current study.

Other names: ALGRX 4975, ADLEA

Primary outcomes

  1. changes in sensory function before and 2 years after groin hernia repair in patients with and without capsaicin instillation, evaluated by quantitative sensory testing

    Time frame: 2 years

Secondary outcomes

  1. Frequency of chronic pain

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Cutaneous Sensory Function After Wound Instillation of Capsaicin During Groin Hernia Repair

Important dates

Study start
2008
Study completion
2008
First posted
Dec 31, 2007
Registry last updated
Jan 30, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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